Phase 1 and 2 studies of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP)

Cempra Pharmaceuticals announced that it is enrolling patients in a Phase 2 study of orally dosed solithromycin for the treatment of community-acquired bacterial pneumonia (CABP), as well as the initiation of a Phase 1 study of intravenous (IV) solithromycin. The Phase 2 trial is multi-center, randomized and double-blind comparing the safety and efficacy of oral solithromycin to levofloxacin in 150 patients with moderate-to-moderately severe CABP. The Phase 1 trial is a single and multiple dose escalating study in healthy adults evaluating the safety, tolerability, and pharmacokinetics of the IV formulation of solithromycin.

Solithromycin (CEM-101) is a fluoroketolide, the first of a new generation of macrolide-ketolide antibiotics, which has potent in vitro activity against respiratory pathogens such as pneumococci, including those that are macrolide- and quinolone-resistant.